Device to permit offpump beating heart coronary bypass surgery

ABSTRACT

A suction cup adapted to engage a surface of a beating heart with sufficient force to move the beating heart to an unnatural position upon moving the suction cup, while the suction cup maintains engagement with the surface of the heart and the heart continues to beat. Various suction cups are described each including at least a first chamber having a flexible rim and configured to engage the surface of the beating heart and a second chamber smaller than the first chamber and fluidly connected therewith. A suspension device configured to engage a beating heart and maintain engagement via suction while moving the suspension device to move the beating heart to an unnatural position and maintain the beating heart in the unnatural position to perform a surgical procedure, while the heart continues to beat, includes a suction cup and a support arm connected thereto. The suction cup has a first chamber configured to engage the surface of the beating heart and a second chamber smaller than the first chamber and fluidly connected therewith. The second chamber is adapted to fluidly connect the first chamber with a source of suction. The support arm is movable with the suction cup to effect movement of the beating heart after engagement of the suction cup to a surface of the beating heart. A method of manipulating a beating heart to orient the beating heart in a desired position for performing a surgical procedure includes providing a suction cup having a first chamber configured to engage the surface of the beating heart, and a second chamber smaller than the first chamber and fluidly connected with the first chamber, the second chamber being further fluidly connected to a source of suction; contacting a surface of the beating heart with the first chamber; applying suction between the first chamber and the surface of the beating heart, thereby engaging the suction member with the surface of the beating heart; and moving the suction member while maintaining engagement with the surface of the beating heart, thereby moving the beating heart.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of co-pending U.S. applicationSer. No. 10/863,409 filed Jun. 8, 2004, which is a continuation of U.S.application Ser. No. 10/698,798 filed Oct. 31, 2003, now U.S. Pat. No.7,377,895, which is a continuation of U.S. application Ser. No.09/956,418 filed Sep. 18, 2001, now U.S. Pat. No. 6,743,170, which is acontinuation of U.S. application Ser. No. 09/087,511 filed May 29, 1998,now U.S. Pat. No. 6,338,712, which is a continuation-in-part of U.S.application Ser. No. 8/936,184 filed on Sep. 17, 1997, now U.S. Pat. No.6,019,722. This application claims priority to U.S. application Ser.Nos. 10/863,409, 10/698,798, 09/956,418, 09/087,511 and 08/936,184, eachof which is incorporated herein, in its entirety, by reference thereto.U.S. Pat. Nos. 7,377,895; 6,743,170; 6,338,712 and 6,019,722 are alsohereby incorporated by reference thereto, in their entireties.

TECHNICAL FIELD OF THE INVENTION

The present invention relates to the general art of cardiac surgery, andto the particular field of heart retractors used in beating heartsurgery.

BACKGROUND OF THE INVENTION

There are as many as 300,000 coronary bypass graft procedures performedannually in the United States. Each of those procedures may include oneor more graft vessels. Currently, each graft vessel must be handsutured. As many as four or more grafts are placed in a procedure. Untilrecently, coronary artery bypass procedures have been performed with thepatient on cardiopulmonary bypass whereby the heart is stopped withcardioplegia and the surgery performed on an exposed and still heart.

Some pioneering surgeons are performing procedures in which the coronarybypass is performed on a beating heart. That is, without heart-lungbypass and cardioplegia. This minimizes the time it takes to perform theprocedure and reduces the cost of the operation by eliminating theheart-lung bypass machine.

Coronary Artery Bypass Grafting (CABG) is performed and a new bloodsupply to the heart muscle is established when coronary arteries areblocked with calcium or plaque. A new blood supply conduit is joined tothe diseased coronary, distal to the blockage, thus providing a freshsupply of oxygenated blood to the vessel in question. Today, this isaccomplished by hand suturing a graft vessel (the new supply of blood)to the diseased vessel. This junction is called an anastomosis ofvessels. Many different types of supply conduits can be used. Examplesare cadaver vein, saphenous vein, radial artery, internal mammaryartery, and the like.

By way of background, the basic operation of a heart will be brieflydiscussed. The heart works like a pump. The left and right ventriclesare separate but share a common wall (the septum). The left ventricle isthicker and pumps the blood into the systemic circulation. The work itperforms is much greater than the right ventricle. The right ventriclepumps blood into the pulmonary circulation, which is a low pressurecircuit. The right ventricle wall (a low energy system) is much thinnerthan the left ventricle.

The left ventricle fills in diastole and ejects in systole. Thedifference between the diastolic volume (largest) and the systolicvolume (smallest) (the stroke volume or amount of blood ejected on eachheartbeat) multiplied by heart rate determines the cardiac output of theheart (liters/min. of flow). The heart shortens during systole as themuscle contracts. There are a number of motions during contraction(including a considerable amount of rotation) but for practical purposesthe heart can be thought of as a truncated cone. Shortening occurs alongits length and also along its diameter. For purposes of this disclosure,the more important of the two motions is the shortening along thediameter since the ejection volume varies as the square vs. along thelength which varies with the first power.

The heart functions well whether the person is upright, upside down,prone or supine. It sits inside the pericardium—a sac which limits itsmotion and spreads the support on the heart so that no matter how aperson position himself, it is not particularly compressed and is ableto fill and then eject with each heartbeat. The concept of thepericardium spreading the load is critical, i.e., when lying supine, theposterior pericardium supports the heart over a large surface of theheart just as when the person is lying on his stomach, the front of thepericardium spreads the load.

When the chest is opened by a median sternotomy it is possible to gainaccess to all chambers and surfaces of the heart. This combined with thefact that this incision is usually less painful than a thoracotomy (ribseparation), makes this the preferred surgical approach to the heart.

The coronary vessels are surface vessels, only occasionally dipping intothe myocardium making them accessible without opening the heart.Traditionally, bypass surgery is done with the heart arrested. Thisstops the motion of the heart and allows die arrest of the coronarycirculation so die surgeon sews in a bloodless and easy to see field.Since the heart is stopped, the patient would suffer irreversible damageto the brain and other tissue and organs without the use of theheart-lung machine to support the general circulation. Although theheart-lung machine has been refined, it is particularly toxic to olderand debilitated patients and it is expensive.

It is possible to perform surgery off bypass, while the heart is beatingand the coronaries are under positive blood pressure; however, there maybe problems. One problem is that not all vessels are accessible sincesome vessels are on the posterior or inferior surfaces and that whensuch vessels are brought into view by lifting the heart, cardiacperformance is impaired such that the cardiac output falls and bloodpressure drops. A second problem is that the heart moves so thatsuturing in vessels (12 to 15 stitches in a vessel under 2 mm indiameter) might be inaccurate and a third problem is that there is bloodin the field as the coronary circulation is not interrupted. This lastproblem is now largely solved by snares, which temporarily stop the flowof blood through the targeted arteries. The problem of lifting the heartis not to impair the performance of the heart while at the same timeadequately exposing the heart and regionally immobilizing a vesselduring beating heart surgery, and this problem is not solved with anyprior art system.

For the heart to be effective, it must have adequate biventricularfunction (both right and left ventricles). it must have adequatebiventricular function (both right and left ventricles). The leftventricle pumps into the high resistance systemic circulation and isthicker and generates considerably more energy than the right ventricle.It is primarily circular in cross section. This displacement of blood(and thus heart output) depends on shortening in the short axis(diameter of the cross section) and to a lesser degree on shortening inthe long axis (apex to base). There is also rotational motion to theheart as it contracts, thus imparting multiplanar motion to the heart asit beats; still further, the surface of the heart undergoes multiplanarmovement during operation of the heart. The right ventricle pumps intothe lower resistance pulmonary circulation and is much thinner and itsenergy generation is much less than that of the left ventricle. Functionof both of these ventricles must be maintained during surgicalmanipulation of a beating heart.

Therefore there is a significant need for a means and a method formoving a beating heart so as not to impair the performance of the heartwhile at the same time adequately exposing the heart and regionallyimmobilizing a vessel during beating heart surgery.

Lifting of the heart is deleterious to heart function for severalreasons. First, the lifting of the heart impairs the venous return tothe heart so that there is less diastolic filling of the heart (this canlargely be corrected by putting the head down and the feet up toincrease venous return). Second, the heart is distorted. Using a hand orspatula to lift the heart is quite different than simply changing bodyposition when the heart is inside the chest. The force applied by thehand to the heart is localized so that the heart is no longer atruncated cone, but is much flatter. This shape is much less effectivefor ejection (the circle is the most effective as it has the highestratio of volume to diameter) and flattening also limits the diastolicvolumes so that inadequate filling occurs. Third, lifting pressureapplied to a beating heart may deleteriously affect valve function ofthe heart, in particular, the mitral valve function may be adverselyaffected by such lifting.

In order to perform cardiac surgery on a beating hart, there is a needto lift, support and orient the heart without reducing its ability tofunction. Therefore, there is a need for a means and method to move andorient a beating heart into position so any vessel of the heart can beaccessed without unduly interfering with the operation of the heart,especially the mitral valve function.

In coronary bypass operations, grafts have to be anastomosed to theanterior descending artery (right coronary artery branch), thecircumflex artery, and to the posterior descending artery. The anteriordescending artery lies on the front surface of the heart and is easilyaccessible to the surgeon without particular help from surgicalassistants or using any devices. The circumflex and posterior descendingarteries, however, lie on the back surface of the heart. Therefore, toexpose the circumflex artery to a field of view of the surgeon, it ismandatory to lift the heart and rotate it about the axis of the inferiorvena cava and the superior vena cava. Likewise, to expose the posteriordescending artery, it is necessary to lift the heart and rotate it inthe direction of its apex. If the heart is moved improperly, it may gointo fibrillation.

Ordinarily, a surgical assistant is employed to lift the heart by usinghis or her hand, this is satisfactory for an arrested heart. Howeverthis is not satisfactory for a beating heart. However, it is verydifficult and tiring to keep the heart in a steady position.Furthermore, the myocardium in contact with the assistant's fingers maybe damaged by pressure, avulsion, and premature rewarming. Further, theassistant's hand in the operative field can get in the way, and theassistant, who often stands next to the surgeon may restrict thesurgeon's movements.

To date, with the exception of the device disclosed in the parentapplication, devices that have been directed toward facilitating beatingheart surgery have been very simple stabilization platforms. A two-tinedfork is the simplest and works well on directly exposed vessels such asthe LAD. Another device is comprised of a hollow support tube which canbe clamped outside the patient's body cavity. The support tubeterminates in a suction head with a number of suction ports arranged ina linear row in such a way that they resemble the suction cups of anoctopus. These suction heads are attached to the myocardium and ideallyallow the heart to be regionally immobilized on either side of thetarget artery. This allows for a very localized stabilization of anartery to perform an anastomosis. This tool accomplishes therequirements for immobilizing the target artery for surgery. However,this tool is inadequate for actually lifting the heart to gain access tovessels located on the posterior and lateral surfaces (circumflex andright coronary distributions). This device really is a local stabilizer,and cannot be adequately employed to assist in the lifting or moving ofthe heart, which is necessary in some instances, such as for a largeheart, or the like. However, it has also acquired another role, that ofvessel presentation. Unfortunately, the device was not implicitlydesigned for this function. Vessel presentation during beating heartsurgery is a different function and more complex since it must allow theentire heart to function. Yet it is the more commercially valuableapplication of this tool since there are no other mechanical stabilizersavailable which are simple and acceptable to lift the functioning heartto access all vessels and eliminate the need for cardio-pulmonarybypass.

Therefore, there is a need to provide a tool that is commercially viableand which can be used for vessel presentation, and which can be used toassist in lifting and/or orienting the heart when needed.

The surgeon would like a very localized, immobilized area, such as oneto two cm, on either side of the target vessel. The above-mentioned toolimmobilizes the heart transmurally for a distance of two to 3 cm on eachside. Small suction heads, like the surgeon prefers for localimmobilization, unfortunately cannot lift the heart and larger suctionheads impair heart function by immobilizing too large an area around thesuction head. If several rigid heads are used circumferentially aroundthe heart in order to lift it, a large amount of the heart is preventedfrom contraction. This will immobilize too much of the heartcircumference to maintain effective heart function.

Therefore, there is need for a means and method for immobilizing aparticular area on the heart without unduly interfering with thefunctioning of the heart, and which can be used to lift the heart aswell, again, without interfering with the operation of the heart. Thereis also a need for a system for manipulating a heart during cardiacsurgery which will support the heart in position for coronary bypasssurgery of the circumflex coronary artery and posterior descendingartery.

Still further, the myocardium of a beating heart undergoes multiplanarmovement and motion during operation of the heart. A suction cup appliedto such a moving surface may have a tendency to become separated fromthe myocardium thereby interrupting the suction being applied to theheart. Such interruption of suction may interfere with the attachment ofthe device to the heart.

Therefore, there is a need for a means and method for manipulation of aheart during cardiac surgery that will not be impaired by movement ofthe myocardium during operation of the heart.

One remedy for this problem is to make the suction cups larger. However,this is not practical since too much of the myocardium might beinfluenced by such a solution.

Therefore, there is a need for a means and method for manipulation of aheart during cardiac surgery that will not be impaired by movement ofthe myocardium during operation of the heart, while influencing aminimum amount of the myocardium.

Another prior art method of supporting a heart is by use of a sling. Asling is a network of fabric or plastic that is placed around the heartin the manner of a hammock. The heart is then supported by the sling. Itis noted that in order for a sling to work as a retractor, the surgeonis required to arrange the ties to be pulled from the proper direction,such as normal to the desired direction of lift, which can be onerous.This presents a serious problem since there are no easy reference pointsabove the patient in which to attach these ties.

While the art has included several inventions intended to support theheart during coronary bypass surgery of the circumflex coronary artery,these inventions have several drawbacks that have hindered theiracceptance in the art. For example, the use of nets to support the heartexposes the heart to fine strands which impinge on the heart and maycause damage. Furthermore, nets may impede the surgical target andrequire special techniques or procedures to remove the net from thesurgical target area. This is especially onerous if the net mesh isfine. Flat cloth tapes are a form of net, and may damage the heart dueto a rough texture of the cloth and the small area of contact betweenthe tape strands and the heart. Further, tapes and similar devices thatdo not have large surface areas contacting the heart may not support theheart in a uniform manner and may create large pressure areas at thecontact points.

Therefore, there is a need for a manipulation system for use in cardiacsurgery which will support the heart in position for coronary bypasssurgery of the circumflex coronary artery in a manner that will notdamage the heart yet will provide easy access to the surgical target andkeeps working while cardiac output is maintained.

Still further, some prior art means for supporting the heart duringcardiac surgery may tend to interfere with ventricle operation.

Therefore, there is a need for a means and a method for manipulating aheart during cardiac surgery which will not interfere with ventricleoperation of the heart while a beating heart is supported in positionand orientation for surgery.

The parent disclosure discussed a means and method for lifting the heartduring surgery. This means and method included a gross support means forengaging the apex portion of the heart and which is fixed to astationary element, such as the operating table or the like. Thepreferred form of the gross support means includes a cup-shaped elementthat fits around the apex of the heart to support the weight of theheart and which is attached to a source of suction.

The means and method disclosed in the parent disclosure work well, butthe inventors have since discovered that it would be beneficial to theoverall success of beating heart surgery to contact the least amount ofmyocardium as possible in moving the heart for surgery.

A further consideration in coronary artery surgery is hemorrhage fromthe incision into the coronary artery at the proposed anastomotic site.Therefore, heretofore, coronary artery surgery has been carried outunder conditions of cardiac arrest and aortic root cross clamping.Hence, the myocardium is temporarily deprived of coronary blood supply.In some patients, an additional coronary blood supply, through the formof bronchial circulation, causes significant hemorrhage during thebypass grafting process. This hemorrhage is inconvenient, as it masksthe surgeon's view during the delicate suturing process, and threatensthe well-being of the patient. Performing surgery in this manner hasseveral additional drawbacks, including the need to stop the heart, theneed to insert special equipment and procedural steps to carry out thefunction of moving blood through the patient's body while the heart isstopped.

Therefore, there is a need for a heart retractor which will support theheart in position for coronary bypass surgery of all of the coronaryarteries, including the circumflex coronary artery, in a manner suchthat the tool does not damage the heart while cardiac output ismaintained yet will provide easy access to the surgical target and whichcan be used in a manner that does not require the heart to be stopped.

Still further, there is a need for a system for manipulating the heartduring cardiac surgery which permits regional as well as specificimmobilization of the heart.

However, the continued operation of the heart will produce problems, inaddition to the above-discussed problems, of forming a moving target forthe surgeon. That is, since the heart continues to beat during theoperation, the surgical target will move in connection with such beatingmovement. The heart cannot be stopped or unduly constrained withoutincreasing the danger of fibrillation.

Therefore, there is a need for a system for manipulating the heartduring cardiac surgery which will support a beating heart in positionfor coronary bypass surgery of coronary arteries in a manner that willnot damage the heart yet will provide specific and regional supportwhile allowing unabated cardiac output.

Recently, there has been interest in minimally invasive coronary bypasssurgery. This is not surprising since a median sternotomy and a run onthe cardiopulmonary bypass pump are not well tolerated by some patients,combined with the added cost of coronary bypass equipment and staff. Theprocedure results in considerable recovery time and is associated with arisk of death and major complication. While the ultimate goal is toprovide bypass to all vessels by port access (like gallbladder surgery)and to eliminate the need for cardiopulmonary bypass, a more limited butreasonable option for the next number or years will be to perform bypassoff pump with an incision (sternotomy or thoracotomy). A tool whichcould allow performance of multivessel off pump bypass would be mosthelpful.

Therefore, there is a need for a heart retractor which will support theheart in position for minimally invasive coronary bypass surgery ofcoronary arteries, including the circumflex coronary artery, in a mannerthat will not damage the heart yet will provide easy access to thesurgical target without requiring the heart to be stopped yet withoutunduly constraining the heart.

Still further, the inventors have observed that not all hearts are thesame size, shape and have the same spacing between corresponding areas.Thus, while all hearts are basically the same, there may be a variationbetween individual hearts. Therefore, a device that supports a heartshould account for these variations. This is especially true if theheart is to continue pumping during the operation and while it issupported. If the support is not fit to the particular heart, it mayconstrict the heart in some manner and thus interfere with the continuedoutput of the heart.

Therefore, there is a need for a system for manipulating a heart duringcardiac surgery which will support a heart, especially a beating heart,during cardiac surgery and which can be adjusted to fit the particularneeds of the individual heart and will support the heart both in grossand regionally.

OBJECTS OF THE INVENTION

It is a main object of the present invention to provide a system formanipulating a heart during cardiac surgery which will support theweight of a beating heart and maintain cardiac output unabated anduninterrupted even though the heart is maintained in an unnaturalposition and/or orientation.

It is another object of the present invention to improve the retractordisclosed in the parent disclosure.

It is a further object of the present invention to provide a system formanipulating a heart during cardiac surgery which will support a beatingheart in position for coronary bypass surgery and which can support theheart both regionally and in gross.

It is a further object of the present invention to provide a system formanipulating a heart during cardiac surgery which will support a beatingheart in position for coronary bypass surgery and which can support theheart both regionally and in gross and which can account for variationsin individual hearts.

It is a further object of the present invention to provide a system formanipulating a heart during cardiac surgery which will support a beatingheart in position for coronary bypass surgery of the coronary arteries,including the circumflex coronary artery.

It is another object of the present invention to provide a system formanipulating a heart during cardiac surgery which will support the heartin position for coronary bypass surgery of the coronary arteries in amanner that will not damage the heart yet will provide easy access tothe surgical target.

It is another object of the present invention to provide a system formanipulating a heart during cardiac surgery which will support the heartin position for coronary bypass surgery in a manner that will not damagethe heart yet will provide easy access to the surgical target and whichcan be used in a manner that does not require the heart to be stopped.

It is another object of the present invention to provide a system formanipulating a heart during cardiac surgery which can support the heartwhile maintaining competent mitral valve function.

It is another object of the present invention to provide a system formanipulating a heart during cardiac surgery which will support the heartin position for coronary bypass surgery in a manner that preventscollapse of the right ventricle during manipulation of the heart.

It is another object of the present invention to provide a system formanipulating a heart during cardiac surgery which will support the heartin position for coronary bypass surgery in a manner that will not damagethe heart yet will provide easy access to the surgical target withoutrequiring the heart to be stopped yet without unduly constraining theheart.

It is another object of the present invention to provide a system formanipulating a heart during cardiac surgery which will support the heartin position for minimally invasive coronary bypass surgery in a mannerthat will not damage the heart yet will provide easy access to thesurgical target without requiring the heart to be stopped yet withoutunduly constraining the heart.

It is another object of the present invention to provide a system formanipulating a heart during cardiac surgery which will provide regionaland specific immobilization of the heart.

It is another object of the present invention to provide a system formanipulating a heart during cardiac surgery which will isolate oneregion of the heart while allowing cardiac output to be sustained.

SUMMARY OF THE INVENTION

These, and other, objects are achieved by a system for manipulating aheart during cardiac surgery which suspends the heart from the apicalregion near the right ventricle and prevents collapse of the rightventricle during the manipulation. The heart can be supported by thissuspension, but also has a gross support that is located near the leftventricle and extends along the arterial ventricular (AV) groove to liftand rotate the heart while supporting the mitral valve annulus tomaintain competent valve function of the mitral valve. Two-point supportcan thus be provided in a manner that maintains cardiac operationunimpeded. Still further, the system can include a surgical targetimmobilizing means that is, itself, capable of assisting in the liftingof the heart under some circumstances and thus can be used to assist inthe movement of the heart during cardiac surgery. The location anddesign of the elements of the system of the present invention achievesthe lifting and orienting of the heart in a manner that presents theheart in the most advantageous position and orientation for surgerywhile permitting the heart to maintain cardiac output in an essentiallyunabated manner. This provides a stationary target for the surgeon whilesupporting the heart in a safe manner and in a manner that does notinterfere with the surgeon or his field of sight. In this manner, thesystem of the present invention can be used to support a heart duringcardiac surgery without requiring an assistant to hold the heart, yetwill permit the surgical procedure to be carried out without requiringcardiac arrest.

Furthermore, the system of the present invention includes a frame thatis located within the patient's thoracic cavity whereby movement of thepatient automatically moves the heart supporting elements in acorresponding manner. This maintains die surgical work field clear andautomatically repositions and reorients the heart supporting elements asthe patient is moved. This efficiently keeps the heart supported duringsurgery.

More specifically, a first form of the system for manipulating a heartduring cardiac surgery includes an element that can be cup-like andwhich has a flexible rim that engages the myocardium of the heart in amanner that maintains the engagement even while the myocardium movesduring heart operation. Still further, the cup-like element is designedso that heart tissue will not interfere with the operation of theelement. The cup-like element applies suction to the heart to hold theelement associated with the cup-like element on the heart. The cup-likeelement is used in connection with the suspension head discussed aboveas well as in connection with the surgery target immobilizing element.Flexible means on the cup-like element permit that element to move toaccommodate multiplanar movement of the heart during operation of theheart. Still further, the gross support means may also use suction tohold the support against the heart. If used, the suction interface isdesigned so heart tissue will not interfere with the suction applied viathe gross support means. The design of the suspension head, the suctioncups and the surgical target immobilizing means is such that the systemof the present invention can accommodate an individual heart and isamenable to use on hearts of different sizes, weights and evenlocations. In this manner, a heart, especially a beating heart, can besupported in the manner that is most effective for that particularheart. Thus, in the case of a beating heart, cardiac output can bemaintained in an unabated and uninterrupted manner as there will bevirtually no constrictions on the heart because the support will beperfectly fitted the particular heart.

A form of the system of the present invention can be used in minimallyinvasive surgery. The system may include a handle on the gross supportmeans to move the gross support means as required, and a handle can beplaced on the target-immobilizing means to move that means as necessaryas well. The distal ends of the handle are located to provide access tothe handle while remaining unobtrustive during surgery. Detachablehandles could also be used whereby the handles are removed after correctplacement of the head.

While this invention is disclosed in the preferred form for open chestprocedures for beating heart surgery, it may also be utilized forminimally invasive procedures as well as those that use cardioplegia dueto its novel time saving and enabling features. It is also noted thatthis disclosure is not directed to the art of anastomosis per se.However, it is directly related to enabling a surgeon to perform ananastomotic procedure in a precise and controlled manner.

The inventive device disclosed herein eliminates the need for use of theheart-lung machine. It allows a surgeon to lift and displace the heartto expose all vessels to regionally immobilize them for suturing withoutseriously impairing heart performance.

The advances made using the retractor disclosed in the parent disclosureare thus improved.

Once the stabilization of the beating heart has been achieved as withthe system of the present invention, it then becomes more feasible toentertain the idea of performing this surgery in a minimally invasivemanner precluding the need for the median sternotomy.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

FIG. 1 illustrates blood flow in a normal heart

FIGS. 2A-2E illustrate the pumping action of a normal heart.

FIG. 3 is a sectional elevational view of the system for manipulating aheart during cardiac surgery disclosed in the parent application.

FIG. 4 is a bottom view of the system for manipulating a heart duringcardiac surgery disclosed in the parent application.

FIG. 5 is a perspective view of the system for manipulating a heartduring cardiac surgery of the parent application in place on a heart.

FIGS. 6A and 6B illustrate operation of a prior art suction cup.

FIGS. 7A and 7B illustrate operation of a multipart suction cupembodying the present invention.

FIG. 8 is a perspective view of a system for manipulating a beatingheart during cardiac surgery embodying the present invention.

FIG. 9 is an elevational view of the system for manipulating a heartduring cardiac surgery in place on a heart.

FIG. 10 shows the FIG. 8 retractor in place in a patient.

FIG. 11 is a view taken along line 11-11 of FIG. 10.

FIG. 12 shows a portion of the gross support means of the retractor ofthe present invention.

FIG. 13 is a top plan view of the flexible-head of the gross supportmeans of the retractor.

FIG. 14A is a view along line 14A-14A of FIG. 13 showing the mesh meansthat prevents heart tissue from interrupting suction applied to maintainthe gross support means in place on the heart.

FIG. 14B is an exploded view of the gross support means shown in FIG.12.

FIG. 14C is an exploded view of the gross support means in largerdetail.

FIG. 15 shows a portion of a preferred form of the mesh means.

FIGS. 16A and 166B show the flexible multisection suction cup of thepresent invention.

FIG. 17 shows another form of the multisection suction cup.

FIGS. 18A and 18B show another configuration of the flexible suction cupof the present invention.

FIGS. 19A and 19B show another form of the multisection suction cup.

FIGS. 20A and 20B show another form of the multisection suction cup.

FIGS. 21A and 21B show another form of the multisection suction cup.

FIGS. 22A and 22B show another form of the multisection suction cup.

FIG. 23 shows a bottom plan view of a prior art tool used to immobilizea section of a beating heart to define a surgical target.

FIG. 24 is a bottom plan view of a means of the present invention forimmobilizing a surgical target area of a beating heart.

FIG. 25 is an elevational view of the means of the present invention forimmobilizing a surgical target area.

FIG. 26 is a perspective view of an alternative form of the retractor ofthe present invention.

FIG. 27 shows an alternative form of the system for manipulating theheart during cardiac surgery embodying the present invention.

FIG. 28 is a top view of the system shown in FIG. 27.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE INVENTION

By way of introduction, the operation of a heart will be discussedbefore describing the system embodying the present invention. In FIG. 1,the normal circulatory pattern of blood through heart 10 is illustrated.Blood from the venous system enters the first chamber of the heart, theright atrium (R.A.) 12. From right atrium 12, it passes throughtricuspid valve 14 into right ventricle (R.V.) 16 via pulmonic valve 18,entering pulmonary artery 20 which leads to lungs 22. In lungs 22,carbon dioxide is released and the blood is reoxygenated. Blood thenexits lungs 22 back into pulmonary vein 24 which leads to left atrium(L.A.) 26. From left atrium 26, blood passes through mitral valve 28into left ventricle (L.V.) 30. Blood then exits heart 10 via aorticvalve 32 into aorta 34 and the generalized arterial circulation.

Cardiac contraction is orchestrated by electrical impulses originatingfrom the heart's nervous system. Electrical stimulation to themyocardial fibers results in muscular contraction. Specifically timedelectrical signals originating in the upper chambers of the heart causethe atriae to contract and empty blood into the ventricles 16 and 30.After atrial contraction, a short electrical delay takes place. Thispause allows the ventricles 16 and 30 to receive blood from atriaebefore they are stimulated to contract. With ventricular contraction,blood is ejected from heart 10.

FIGS. 2A-2E illustrate a simplified diagram of normal cardiaccontraction as visualized from left ventricle 30. The cardiac cycle canbe broken down into two major stages: diastolic and systolic. Diastolicis the relaxation phase of the ventricular contraction cycle. Duringthis time the ventricle relaxes and fills up with blood in preparationfor the next contraction. Systole is the ventricular phase involved withcontraction and the process of ejecting blood from the heart.

FIG. 2A illustrates the first phase of diastole which is isovolumetricrelaxation immediately following a systolic contraction. This representsthe transition phase between diastole and systole.

FIG. 2B illustrates that with further ventricular relaxation, a buildingof negative pressure within the ventricle due to dilation results in arapid influx of blood. Additionally, the geometric angle formed betweenthe ventricular wall, papillar muscle (P.M.) 36, chordac tendinea (C.T.)38 and mitral valve (M.V.) 28 widens. This combined process results inthe opening of mitral valve 28.

FIG. 2C illustrates the latter stages of diastolic ventricular filling.During this phase, left atrium 26 contracts to allow for maximalventricular filling.

In FIG. 2D, left ventricle 30 begins to build muscular tension prior toactually contracting and secondarily reducing ventricular volume. Thisphase demonstrates isovolumetric contraction and is referred to aspre-systole. With building ventricular contraction, the intraventricularpressure increases which helps force mitral valve 28 closed.Additionally, the geometric relationship between the valve cusp andmuscle-tendon supporting structures narrows with ventricular contractionwhich assists in mitral valve closure.

FIG. 2E illustrates that as ventricular contraction progresses, theintraventricular volume decreases and pressure builds. Once theventricular pressure exceeds the blood pressure within aorta 34, aorticvalve (A.V.) 32 is pushed open. Blood is then ejected from theventricular cavity into aorta 34. This phase is called systole.

By way of further introduction, the retractor disclosed in the parentdisclosure will be briefly discussed. The retractor disclosed in theparent disclosure clamped the heart in a manner that restricts thelength dimension while permitting the other dimensions to change. Byimmobilizing the heart in a direction along dimension L, but allowingthe remainder of the heart to operate in a normal manner, operation ofthe heart is not restricted. The retractor of the present inventionfurther immobilizes only the specific surgery target area whereby theremainder of the heart operates in an unrestricted manner. Thus, onlythe specific surgery location is immobilized. This is all that isrequired for a successful surgery and the entire heart need not beimmobilized. The system for manipulating a heart during cardiac surgeryof the present invention also lifts the heart in a manner that permitsunrestricted operation of the heart as well.

Since the present invention is an improvement over the parent disclosedinvention, it will be instructive to briefly review that parentretractor. Further discussion of the parent retractor can be found inthe parent disclosure which is incorporated herein by reference.Referring specifically to FIGS. 3-5, a system for manipulating a heartduring cardiac surgery 50 of the parent invention is shown in detail.The retractor permits regional and specific immobilization of the heartwhile permitting essentially unabated cardiac output whereby allcoronary arteries, including the circumflex coronary artery, to bebypassed and the heart maintained in an unnatural position and/ororientation. The retractor includes a gross support means 52 forengaging an apex portion (gross weight) of a heart to support the heartwhen the heart is lifted for surgery. Support means 52 includes acup-shaped portion 54 having a top rim 56 and an apex 58 with ribs 60defined adjacent to the apex to support the heart in the cup-shapedelement. While a cup-shaped element is preferred, one could substituteother attachment configurations without departing from the scope of thisdisclosure. The only requirement is that the element be sized and shapedto adequately support the heart to achieve the results discussed herein,to with: supporting the heart in an orientation suitable for the type ofheart surgery of interest here. Thus, no limitation as to specific shapeis intended for element 52. Vacuum ports 62 c and 62 p are definedthrough the cup-shaped element at apex 58 to be fluidically connectedwith a vacuum source for securing the heart in place in the cup-shapedelement. A vacuum source V is fluidically connected to holes 62 via mainsupport arm 64 which has one end thereof fixed to a stationary support S(see FIG. 5), such as the operating table, or a rib spreader, and theother end thereof attached to the cup-shaped element via fastener 66attached to anchor 68. A manifold-like portion 70 of the cup-shapedelement distributes the vacuum to the various ports, such as ports 62 cand 62 p to be applied to secure retractor 50 to the heart. Analternative form of the retractor includes a separate hose 72 totransfer vacuum to the manifold 70. Ribs 60 keep heart fat from cloggingthe vacuum manifold section.

The retractor of the parent disclosure further includes a fine supportmeans for immobilizing selected portions of the heart while permittingnon-immobilized portions to move in a manner that continues heartoperation. This fine support means includes a plurality of rigid arms 80each being fixed at one end thereof to anchor 68 and having aheart-attaching element 82 thereon, such as at the outer end thereof. Asused herein, the term “rigid” is a relative term and means that the armsare rigid enough whereby the force of the heart won't move them. Butthey can be adjustable such as being formed of a wire-wound gooseneck orsoft metal which allows each arm to be individually shaped according tothe needs of the attachment location. The heart-attaching elements canbe suction attachment points, such as suction cups that are fluidicallyconnected to manifold 70. Other means of attaching the elements to theheart, can be used as well without departing from the scope of thepresent disclosure as will occur to those skilled in the art based onthe teaching of this disclosure. Examples of other such elements includeglue, sutures, clamps, shallow pins, pincers or the like, withattachment points being located on the arm as suitable. The rigid armssecure small or fine areas of the heart in place with respect to grosselement 52 while permitting the heart to move as required to continueunabated cardiac output. Support means 50 further includes a pluralityof flexible support arms 84 each fixed at one end thereof to anchor 68and having a heart-attaching element 86 on the outer end thereof.Elements 86 can be suction elements similar to the just-discussedelements 82. Flexible arms 84 can be adjusted to secure the heart in themost advantageous locations whereby the heart can continue to operatewithout undue restriction.

Therefore, broadly, the overall parent retractor comprises a mainsupport which includes the arms, the hub and a stationary member, suchas a table top, the floor or the like; a gross support which includesthe apex cup and fine support means which regionally immobilizesportions of the heart while leaving other regions of the heart free tooperate in an unabated manner to maintain heart output during thesurgical procedure. The fine support means can include the rigid arms aswell as the surgery target immobilizing means. In this manner, the heartis supported regionally yet operates to maintain blood flow duringcoronary surgery.

Referring to FIG. 5, it can be seen that parent retractor 10 includes asurgery target-immobilizing element 100 for immobilizing that exactlocation of the heart on which surgery is being performed. Element 100includes a rigid arm 102 fixed at one end 104 to connecting arm 106 ofstationary main arm 64 and having a U-shaped target-defining element.108 on the other end. Element 108 includes two legs 110 and 112connected by a central section 114. As shown in FIG. 5, the target vein116 being incised at 118 is located between legs 110 and 112. Element108 is rigid as is arm 102 so target area 118 will be immobile eventhough the remainder of the heart adjacent to this area will be moving.However, only a small section of the heart will be immobilized and thusshould not affect the overall operation of the heart during theoperation. The target-immobilizing element can be moved anywhere it isneeded by simply loosening clamp 120 and moving arm 102 as necessary.

As was discussed in the parent disclosure, during operation of theheart, the left ventricle is a conical shaped cavity which is narrowestat the apex. It shortens both in length and in diameter during a pumpingstroke (contraction). Since the volume of blood displaced is moredependent on the reduction in diameter (square) than the shortening inlength (first power), any measure which reduces the shortening of thediameter is very detrimental. Also, the right ventricle is attached tothe left ventricle and is considerably thinner and less powerful.Suction attachments to this part of the heart which would impede theshortening of muscle may be poorly tolerated. The invention disclosedand taught herein uses a series of linked attachments to the heart.Attachments which are near the artery to be bypassed are paired onopposite sides of the artery and do not move—they immobilize the arteryand therefore the muscle in the target region. A lifting suction isapplied at the apex of the heart. If this were the only site of lifting,the heart would be stretched and there would be no diameter left. Thus,no blood could be ejected. However, this invention adds additional heartattaching elements that are attached to the heart to lift it. Theseattachment points would be mobile in that they could allow the heart tomove inward and reduce the diameter and eject blood. The key to theinvention is the linking of lifting (both at the apex and around thecircumference of the heart) and regional immobilization which stops onepart around the circumference from moving and therefore allows easysuturing.

As discussed above, while the parent retractor works well, it can beimproved. Referring to FIGS. 6A-28, a system for manipulating a heartduring cardiac surgery is shown which has improved operation over theparent retractor.

The heart manipulation system of the present invention utilizes aspecial suction cup to attach various elements thereof to the beatingheart in a manner that permits the heart and the myocardium to moveduring heart operation without unduly affecting the attachment of theelement to the heart.

Specifically, the suction cup of the present invention applies suctionto the heart surface from a source of suction (not shown, but discussedin the parent disclosure). Suction cup 200 of the present invention isbest shown in FIG. 7A which shows a suction cup that is most useful withnon-flaccid tissue in which it is easier to make the suction cup conformto the tissue than to force the tissue to conform to the suction cup,and FIG. 7B which shows a suction cup that is most useful with flaccidtissue which is easier to force to conform to the shape of the suctioncup. Both suction cups 200 can be compared to a prior art suction cup Sshown in FIGS. 6A and 6B. As shown in FIGS. 6A and 6B, prior art suctioncup S includes a single chamber C that is fluidically connected to asuction line L and which has a rim R for engaging the surface, such astissue T, to which suction cup S is attached. Suction pressure isapplied over an area A which corresponds to the area of the suction lineL. As will be understood by those skilled in the art, if tissue T movesit can move away from rim R thereby breaking the suction being appliedto tissue T. Still further, if tissue T moves, it might move intosuction line L thereby interfering with application of suction to thetissue, as is indicated in FIG. 6B. This latter situation is likelysince the maximum suction force is applied over area A and will tend todistort tissue T in the manner indicated in FIG. 6B. Such distortionalso tends to move the tissue away from rim R.

However, suction cup 200 shown in FIGS. 7A and 7B does not have thesedrawbacks because it includes a plurality of chambers and a means forpreventing tissue from interfering with suction being applied thereto.Specifically, suction cup 200 is a multi-section suction cup whichincludes a first chamber 202 having a flexible rim 204 for engaging thetissue M of a heart, and a second chamber 206 for fluidically connectingfirst chamber 202 the source of suction via suction line 208. Secondchamber 206 of the suction cup has a size that is different from thesize of first chamber 202, and a shoulder 209 is formed at theconnection between first and second chambers 202 and 206. A mesh gridelement 210 is connected to the suction cup, preferably adjacent toshoulder 209, and spans second chamber 206. Flexible rim 204 is flexiblein a plurality of planes to accommodate multiplanar movement of thesurface of the beating heart without breaking contact between thesurface of the heart and flexible rim 204.

As can be understood from FIGS. 7A and 7B, suction cup 200 will notbreak suction with tissue T even if the tissue is drawn into the suctioncup and a large area of applied suction is maintained due to the largearea A′ of second chamber 206 vis a vis area A of suction cup S. Thus,suction cup 200 is able to adapt to movement of the heart and movementof the myocardium while maintaining a large suction force on the tissue.This permits smaller amounts of myocardium to be affected by the systemof the present invention than even the parent retractor. Since chamber202 is large, rim 204 can be large and thus its flexibility can beincreased over rim R of suction cup S. This permits rim 204 of suctioncup 200 to follow movement of tissue T far better than rim R of suctioncup S.

Suction cup 200 is the best mode used in the present invention; however,other forms of suction cups can be used without departing from the scopeof the present invention and disclosure. The other forms of the suctioncup will also have at least one first chamber and one second chamber anda flexible rim as well as a mesh grid element preventing tissue frominterfering with suction applied via the suction cup. Other forms of thesuction cup are indicated in FIGS. 17 and 18A through 22B, with FIG. 17showing a multiplicity of chambers and a multiplicity of shoulders;FIGS. 18A and 18B showing an off center chamber 202′; FIGS. 19A and 19Bshowing a plurality of suction lines 208′ and 208″; FIGS. 20A and 20Bshowing a reinforcing ring RR surrounding suction line 208′″; FIGS. 21Aand 21B showing a ring RR′ around a plurality of suction lines; andFIGS. 22A and 22B showing a suction cup 200K having a kidney-shapedperimeter. One or more suction lines can be associated with cup 200K asis indicated in FIG. 22A. Suction cup 200 has walls 200W and 200W1 thatare oriented at a sharper angle with respect to base 200B of the suctioncup than are the wall W of suction cup S. This permits the walls of cup200 to be more flexible than the walls of cup S.

Mesh grid element 210 functions to preserve suction pressure on thetissue even if the tissue is drawn into the suction cup. Thus, mesh gridelement 210 has a first portion that can be engaged by the tissue, and asecond portion that will remain open even when the first portion isengaged by tissue. An example of such a mesh grid element is shown inFIG. 15 as including a first portion 212 and a second portion 214 thatare arranged orthogonally with respect to each other. Thus, even iftissue engages portion 212, that tissue will be spaced from portion 214and a fluid passage will remain open between the tissue and the sourceof suction thereby maintaining suction force on the tissue. Other formsof the mesh grid element can be envisioned by those skilled in the artbased on the teaching of this disclosure, and such other forms are alsointended to be encompassed by this disclosure.

As will be evident to those skilled in the art based on the teaching ofthe present disclosure, this flexible rim multi-chamber suction elementwith a mesh grid element will be used in those elements of the heartmanipulation system of the present invention that engage the heart toapply force to the heart to move and manipulate that heart duringcardiac surgery.

A heart manipulation system 300 for use in cardiac surgery is broadlyshown in FIG. 8 as comprising a frame 302 that, as indicated in FIG. 11,is located within the patient's thoracic cavity during beating heartsurgery and which includes means for engaging the pericardial cavity ofthe patient for mounting said frame on the patient to move with thepatient if the patient is moved or re-oriented during surgery.

Frame 302 includes a cross bar 303 that includes a multiplicity of teeth303T thereon for a purpose that will be understood from the followingdisclosure. Frame 302 further includes means for engaging the patient tosupport the frame in position in the patient. A preferred form of thismeans includes two sternal spacers 304 which set the depth of the frameinto the chest cavity and keep the frame from twisting as the lungsinflate and which are connected on cross bar 303 by a ratchet-likemechanism 305 that has teeth which engage teeth 303T when the pacers arein the desired location. The frame is expanded inside the pericardialcavity with the cross bar. A handle 305H is operated to set the teeth ofthe mechanism 305 to teeth 303T. The frame can be either C-shaped orhoop shaped and can be secured to the patient or to an outside stablesupport. Other anchor means can be used as will occur to those skilledin the art based on the teaching of the present disclosure, and thesemeans are intended to be within the scope of this disclosure as well.

As was the case in the parent disclosure, a source of suction is locatedoutside the patient and is used to attach various elements to thepatient's heart. Most often, a source of vacuum is from the operatingroom source which provides approximately 100 to 180 mm of Hg vacuum. Thesource of suction is not shown herein as those skilled in the art willunderstand where such source is best located and what source is bestsuited to the particular application based on the teaching of thepresent disclosure.

As shown in FIG. 8, system 300 includes a suspension head mechanism 312movably mounted on frame 302 for lifting the heart. Mechanism 312includes a head 314 which engages the heart and which is shown in FIG. 9as being located near the apical region of the right ventricle toprevent collapse of the right ventricle during manipulation of theheart. As is also shown in FIG. 9, suspension head 314 at leastpartially overlies the right ventricle. Suspension head mechanism 312includes a flexible means 316, such as a spring, for connecting flexiblehead 314 to arm 318 and for permitting multiplanar relative movementbetween the beating heart and arm means 318 mounting suspension head 314on frame means 302. Suspension head 314 includes a suction cup such asdisclosed above in FIGS. 7A and 7B connected to the source of suctionand which includes a flexible rim engaging the myocardium of the heartand being flexible in a plurality of planes so multiplanar movement ofthe myocardium during operation of the heart will be accommodated by theflexible rim whereby suction applied to the myocardium by the suctioncup will not be broken by separation of the myocardium from the suctioncup. As discussed above, the suction cup of head 314 includes means,such as the above-discussed mesh grid, for preventing heart tissue frominterfering with suction being applied to the myocardium via head 314.

Arm 318 is flexible in one condition as discussed in the parentdisclosure, and is made rigid by manipulation of control and anchorelement 324. Anchor element 324 includes a base 324A which is movablymounted on cross bar 303 and has internal teeth that engage teeth 303T,and a lever system for locking the internal teeth of element 324 toteeth 303T when desired. A further lever-operated mechanism lockscorresponding elements in arm 318 whereby arm 318 is rendered rigid. Arm318 includes a flexible central line extending from head 314, throughflexible element 316 to anchor element 324 and a plurality of relativelymovable sections, such as balls 326 interposed between links 328, on thecentral line. A lever 330 is connected to the central line and when thelever is operated, the elements 326 and 328 are forced together torender the arm rigid. In this manner, the suspension head 314 can beeasily maneuvered on a flexible arm into the desired position and thenlocked into that position by rendering arm 318 rigid. Flexible means 316permits multiplanar movement of suspension head 314 even after arm 318is made rigid whereby movement of a beating heart is accommodated bysuspension head mechanism 312. When suction is applied to the heart viahead 314 the heart will be suspended and can be lifted into the desiredposition and orientation for cardiac surgery without interruptingcardiac output. The combination of the suction cup, the flexible/rigidarm, the flexible means and the location of the head on the heart effectthis result. Various forms of head 314 can be used without departingfrom the scope of the present invention, and a second form of the headis shown in FIG. 17 as head 314′ and which includes a multiplicity ofchambers. Any of the suction cup forms shown in FIGS. 16A-22B can alsobe used for head 314 if desired.

With the heart supported by suspension means 312, the cardiac surgerycan be completed if desired. As will be discussed below, however,additional support can be provided. Cardiac surgery was discussed aboveand in the parent disclosure, reference being made thereto for suchdiscussions. As was discussed, a surgery target immobilizer is used tolocally immobilize the heart while permitting the non-engaged portionsof the heart to continue to operate so as to maintain cardiac outputessentially unabated. Shown in FIG. 23 is a surgery target immobilizerSI discussed in the parent disclosure. Immobilizer SI includes two rigidsections, such as section SIR, each of which includes a plurality ofsuction cups 200 fluidically connected to a source of suction via a lineL to be attached to the heart with the surgical target immobilized forsurgery.

The system of the present invention improves this by including a means340 for locally engaging a selected section of the heart and locallyimmobilizing the heart adjacent to a surgery target so the heart issupported by the suspension head mechanism and can receive furthersupport from the surgery target immobilizing means and can thus be freeto operate during surgery while it is also locally immobilized at thesurgery target with non-engaged sections of the heart free to move in amanner whereby essentially unabated cardiac output is maintained whilethe heart is locally immobilized. The surgery target immobilizing means340 of the present invention includes a flexible section 342, such assuction cup 200, on each rigid element SIR. The suction cups 200attached to each rigid element function and operate as discussed aboveand shown in FIGS. 24 and 25 are connected to the source of suction andeach includes a flexible rim engaging the myocardium of the heart andbeing flexible in a plurality of planes so multiplanar movement of themyocardium during operation of the heart will be accommodated by theflexible rim of the surgery-target immobilizing means whereby suctionapplied to the myocardium by the suction cup of the surgery targetimmobilizing means will not be broken by separation of the myocardiumfrom the suction cup of the surgery target immobilizing means. As wasdiscussed above, suction cups of the surgery target immobilizing meanseach include means for preventing heart tissue from interfering withsuction being applied to the myocardium via said suction cup of thesurgery target immobilizing means.

As discussed above, in some circumstances, two point support ispreferred when performing cardiac surgery. Accordingly, manipulationsystem 300 of the present invention provides a gross support means 400movably mounted on frame 302 for engaging the heart to support the heartwhen the heart is oriented for surgery and which is located at the baseof the heart and which cradles the myocardium of the left ventriclealong the arterial ventricular groove (AV). Gross support means 400 isshown in FIGS. 8, 9, 12, 13, and 14A-14C. As broadly shown in FIG. 8,gross support means 400 includes a head 402 that is engaged with theheart and which is movably connected to frame 302 by an arm mechanism403 similar to arm 318 to be flexible and movable with respect to theheart and with respect to frame 302 when desired, and then renderedrigid by operation of a lever 404 of an anchor mechanism 406 that can belocated on cross bar 303 or on one of the sternum retractors 304.Operation of the flexible arm 403 is identical to that of arm 318 andthus will not be again discussed.

Gross support means 400 supports the mitral valve annulus to maintaincompetent mitral valve function and head 402 is placed beneath aninfolded section of myocardium. Gross support means 400 includes ahandle 408 which is attached to head 402 and which extends outside ofthe patient during surgery for adjusting the location of gross supportmeans head 402.

Head 402 is shown in FIGS. 12-14C as including a rigid support section406 connected to a flexible section 488 having malleable rod means 410received in bores 411 defined in head 402 for retaining a configurationthat has been set for head 402 and for connecting head 402 to the arm403 for mounting gross support means 400 on frame 302. Head 402 caninclude a plurality of sections which are movable relative to each otherand means for maintaining those sections in a selected relativeorientation. In this manner, head 402 can be shaped to best support theheart and can be adjusted to meet the needs of an individual heart. Ashead 314 is also adaptable to the size and shape of an individual heart,the two-point support of system 300 can be adjusted and customized tofit the exact needs of each individual heart. The flexible andadjustable feature of head 402 is indicated in FIG. 13.

As shown in FIG. 14A-14C, head 402 includes means for applying suctionfrom the source of suction to the heart. As best shown in FIG. 14A, thismeans includes a mesh grid means 210 attached to head 402 and spanning afirst chamber 420 above a suction applying manifold 422 that isfluidically connected to the source of suction by a suction line forpreventing heart tissue from interfering with suction applied bysuspension head 402 to the heart. A frame 424 maintains mesh grid means210 in place on head 402, and ribs, such as rib 426 and rib 428 can beused to maintain the desired position of mesh grid element 210 withrespect to suction holes 208 at the end of the suction line.

Using the system 300, a method of performing heart surgery comprisessteps of placing frame 300 in the patient, slightly infolding the leftatrium of a heart adjacent to the base of the heart, engaging the heartunder the edge of the myocardium at the base of the heart with grosssupport means 400 then using handle 408 tilting and lifting the heart.The heart is engaged near the apex of the heart with suspension head 314to lift the heart. Such engagement prevents right ventricle collapse.This provides two point support if desired. However, as discussed above,the suspension means alone may be sufficient in some cases to move theheart as necessary. The method can further including a step of usingsurgery target immobilizing means 340 shown in FIG. 24 to apply suctionto the heart adjacent to the selected surgical target for engaging thatselected section of the heart and immobilizing that selected section asa surgery target while permitting non-engaged sections of the heart tomove and permitting essentially unabated cardiac output to be maintainedwhile the heart is regionally immobilized.

Alternative forms of the frame 302 can be used without departing fromthe scope of the present disclosure, just so the frame is located tomove with the patient. Thus, a frame 302′ shown in FIG. 26 can be used.Frame 302′ essentially completely surrounds the heart and includeselements 304′ for engaging the patient to support frame 302′ in place. Ahandle 302H can be used to adjust the location of frame 302′. Handle302H includes a knob 302K which operates a pinion system for engagingteeth 303T to adjust the size of the frame circumference as indicated byarrow 302S in FIG. 26.

Yet another form of the manipulation system of the present invention isshown in FIGS. 27 and 28. System 300″ includes a gross support system500 which extends around the heart near the base of the heart and whichcan include a plurality of suspension heads 314″ located at variouslocations on the heart, including near the apical region and which areconnected to flexible/rigid arm 502 which corresponds in structure toarms 318 and 403 discussed above and which are mounted on the frame.

It is understood that while certain forms of the present invention havebeen illustrated and described herein, it is not to be limited to thespecific forms or arrangements of parts described and shown.

1-76. (canceled)
 77. A suction cup adapted to engage a surface of abeating heart with sufficient force to move the beating heart to anunnatural position upon moving the suction cup, while the suction cupmaintains engagement with the surface of the heart and the heartcontinues to beat, said suction cup comprising: a first chamberconfigured to engage the surface of the beating heart; and a secondchamber smaller than said first chamber and in fluid communicationtherewith, said second chamber being further adapted to fluidly connectsaid first chamber with a source of suction; wherein at least a portionof said suction cup conforms to a shape of the surface of the beatingheart when engaged therewith under a suction force.
 78. The suction cupof claim 77, wherein said first chamber comprises a flexible rim. 79.The suction cup of claim 78, wherein said flexible rim is flexible in aplurality of planes to accommodate multiplanar movement of the surfaceof the beating heart without breaking contact between the surface of thebeating heart and said flexible rim.
 80. The suction cup of claim 77,further comprising a shoulder formed by a connection between said firstand second chambers.
 81. The suction cup of claim 77, further comprisingan aperture, said aperture being smaller in dimension than said secondchamber and configured to fluidly connect said second chamber to asuction line.
 82. The suction cup of claim 77, further comprising asuction-permeable barrier separating said first chamber from said secondchamber.
 83. The suction cup of claim 82, wherein said suction-permeablebarrier comprises a mesh grid element.
 84. A suction cup adapted toengage a surface of a beating heart with sufficient force to move thebeating heart to an unnatural position upon moving the suction cup,while the suction cup maintains engagement with the surface of the heartand the heart continues to beat, said suction cup comprising: a firstchamber having configured to engage the surface of the beating heart;and a second chamber smaller than said first chamber and in fluidcommunication therewith, said second chamber being further adapted tofluidly connect said first chamber with a source of suction; wherein thesurface of the beating heart conforms to at least a portion of saidsuction cup when said suction cup is engaged therewith under a suctionforce.
 85. The suction cup of claim 84, further comprising a suctionline extending from said second chamber, said suction line adapted toconnect with the source of suction.
 86. The suction cup of claim 85,further comprising an aperture, said aperture being smaller in dimensionthan said second chamber and fluidly connecting said second chamber tosaid suction line.
 87. The suction cup of claim 84, further comprising ashoulder formed by a connection between said first and second chambers.88. A method of manipulating a beating heart to orient the beating heartin a desired position for performing a surgical procedure, said methodcomprising: providing a suction cup having a first chamber configured toengage the surface of the beating heart, and a second chamber smallerthan the first chamber and fluidly connected with the first chamber, thesecond chamber being further fluidly connected to a source of suction;contacting a surface of the beating heart with the first chamber;applying suction between the first chamber and the surface of thebeating heart, thereby engaging the suction member with the surface ofthe beating heart, wherein at least a portion of the suction cupconforms to a shape of the surface of the beating heart contacted; andmoving the suction member while maintaining engagement with the surfaceof the beating heart, thereby moving the beating heart.
 89. The methodof claim 88, wherein said moving comprises lifting the beating heart toan elevated position.
 90. The method of claim 88, wherein said movingcomprises rotating the beating heart.
 91. The method of claim 88,further comprising fixing the suction member in a displaced position tomaintain the beating heart in the displaced position for performance ofthe surgical procedure.
 92. The method of claim 88, further comprisingfixing a support arm connected to said suction member to maintain thebeating heart in the desired position, while said suction cup continuesto permit multiplanar movements of the heart surface engaged by saidsuction cup.
 93. A method of manipulating a beating heart to orient thebeating heart in a desired position for performing a surgical procedure,said method comprising: providing a suction cup having a first chamberconfigured to engage the surface of the beating heart, and a secondchamber smaller than the first chamber and fluidly connected with thefirst chamber, the second chamber being further fluidly connected to asource of suction; contacting a surface of the beating heart with thefirst chamber; applying suction between the first chamber and thesurface of the beating heart, thereby engaging the suction member withthe surface of the beating heart, wherein the surface of the beatingheart contacted conforms to at least a portion of the suction cup; andmoving the suction member while maintaining engagement with the surfaceof the beating heart, thereby moving the beating heart.
 94. The methodof claim 93, wherein said moving comprises lifting the beating heart toan elevated position.
 95. The method of claim 93, wherein said movingcomprises rotating the beating heart.
 96. The method of claim 93,further comprising fixing the suction member in a displaced position tomaintain the beating heart in the displaced position for performance ofthe surgical procedure.
 97. The method of claim 93, further comprisingfixing a support arm connected to said suction member to maintain thebeating heart in a displaced position, while said suction cup continuesto permit multiplanar movements of the heart surface engaged by saidsuction cup.